Events

Rappel de Plasma free of factor VIII coagulation

Selon L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), ce/cet/cette rappel concerne un dispositif en/au/aux/à France qui a été fabriqué par Dade-Behring.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • Date
    2005-07-18
  • Pays de l'événement
    France
  • Source de l'événement
    ANSM
  • URL de la source de l'événement
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-du-dmdiv-plasma-exempt-de-facteur-viii-de-la-coagulation-dade-behring
  • Notes / Alertes
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • Notes supplémentaires dans les données
  • Action
    On July 13, 2005, the company Dade-Behring removed from the market batches 503846A, 503850C and 503853A of the in vitro diagnostic medical device called Plasma free of factor VIII coagulation reference OTXW. In addition, batches 503847D, 503849D, 503849E, 503856B, 503856C, 503857A, 503858A, 503848A, 503859B, 503860D and 536501 of this same device are the subject of recommendations for use. This device is used when assaying coagulation factor VIII activity in human plasma by coagulometric methods. These decisions stem from the possibility of falsely elevated patient outcomes that may lead to misdiagnosis of the severity of hemophilia A or the inability to accurately track substitution therapy. The company has directly notified recipients incriminated lots by means of the attached message validated (13/07/2005) (104 ko) by the Afssaps. The competent European authorities concerned are informed directly by the manufacturer. This information is intended for those responsible for laboratory, the directors of health establishments and the reactovigilance correspondents for dissemination, where appropriate, to the services concerned.

Device

Plasma free of factor VIII coagulation
  • Modèle / numéro de série
  • Description du dispositif
    in-vitro_medical_device
  • Manufacturer
    Dade-Behring

Manufacturer

Dade-Behring
  • Source
    LAANSM